Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults
National Cancer Institute (NCI)
348 participants
Jan 25, 2021
INTERVENTIONAL
Conditions
Summary
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Correlative studies
Given IV
Undergo bone marrow aspiration and biopsy
Given IV
Given IV or IT
Given PO
Given PO or IV
Given IV
Undergo ECHO
Undergo ECG
Undergo lumbar puncture
Given IV
Given IV or IT
Undergo MUGA
Given PO
Given PO
Given IV
Locations(211)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04530565